# K062409: K-Etchant Gel

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Medical, Inc.
- Decided: Nov 8, 2006 after 83 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K943165 (1994). 3 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943165: Clearfil Photo Bond, Kuraray Company, Ltd. (1994) Summary page 1.
- K012432: Modification to Clearfil Photo Bond, Kuraray Medical, Inc. (2001) Summary page 1.
- K031915: Pulpdent Etch-Rite Royale, Pulpdent Corporation (2003) Summary page 1.

## Most influential descendants
- K242675: FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) (2024), 1 descendant of its own
- K080305: Nexcomp and Meta Etchant (2008), 1 descendant of its own
- K260485: Any-Etch (2026), 0 descendants of its own
- K181689: Nexcomp (2018), 0 descendants of its own
- K133078: K-Etchant Syringe; Needle Tip (E) (2013), 0 descendants of its own

## Indications for use
Etching the enamel and dentine for adhesive restorations.

Source page: https://510kreport.com/device/K062409
Methodology: https://510kreport.com/methodology